title: Transdermal application of myelin peptides in multiple sclerosis treatment.
abstract: OBJECTIVE
  Demonstration of efficacious antigen-specific therapy in multiple sclerosis.
  
  
  OBJECTIVE
  To assess the safety and efficacy of transdermally applied myelin peptides in patients with relapsing-remitting multiple sclerosis.
  
  
  METHODS
  One-year double-blind, placebo-controlled cohort study.
  
  
  METHODS
  Referral center.
  
  
  METHODS
  Thirty outpatients aged 18 to 55 years with relapsing-remitting multiple sclerosis.
  
  
  METHODS
  Skin patch with a mixture of 3 myelin peptides, MBP85-99, MOG35-55, and PLP139-155. MAIN OUTCOMES AND MEASURES Cumulative number of active gadolinium-enhanced (Gd+) lesions per patient per scan, mean volume of Gd+ lesions, cumulative number of new T2 lesions, and T2 lesion and T1 lesion volume change from baseline to the end of the study. Total number of relapses during the year of the study per patient (annual relapse rate), proportion of relapse-free patients, and proportion of patients with 3 months of confirmed disability worsening on the Expanded Disability Status Scale at month 12.
  
  
  RESULTS
  All patients completed the study. Compared with placebo, treatment with a myelin peptide skin patch (1 mg) showed a 66.5% reduction in the cumulative number of Gd+ lesions (P = .02) during the 12 months of the study. The annual relapse rate in patients treated with a mixture of myelin peptides (1 mg) was significantly lower compared with the placebo group (0.43 vs 1.4; P = .007). Treatment with a myelin peptide skin patch was well tolerated and no serious adverse events were reported.
  
  
  CONCLUSIONS
  In patients with relapsing-remitting multiple sclerosis, treatment with a myelin peptide skin patch significantly reduced both magnetic resonance imaging and clinically defined measures of disease activity and was safe and well tolerated.
authors.affiliation: Department of Neurology, Medical University of Lodz, Lodz, Poland.
authors.forename: Agata
authors.initials: A
authors.lastname: Walczak
authors.forename: Malgorzata
authors.initials: M
authors.lastname: Siger
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Ciach
authors.forename: Marian
authors.initials: M
authors.lastname: Szczepanik
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Selmaj
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D015331:Cohort Studies; D004268:DNA-Binding Proteins / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005682:Gadolinium; D006801:Humans; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D004676:Myelin Basic Protein / Q000627:therapeutic use*; D009186:Myelin Sheath / Q000473:pathology*; D063308:Myelin-Oligodendrocyte Glycoprotein / Q000627:therapeutic use; D010446:Peptide Fragments / Q000627:therapeutic use*; D055502:Secondary Prevention; D014157:Transcription Factors / Q000627:therapeutic use
chemical_list: D004268:DNA-Binding Proteins; C078341:MYT1 protein, human; D004676:Myelin Basic Protein; D063308:Myelin-Oligodendrocyte Glycoprotein; D010446:Peptide Fragments; D014157:Transcription Factors; C107908:myelin basic protein 85-99; D005682:Gadolinium